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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Enhanced Surveillance System


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P110002 / PAS002
Date Original Protocol Accepted 05/16/2014
Date Current Protocol Accepted 06/03/2014
Study Name Enhanced Surveillance System
Device Name MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
General Study Protocol Parameters
Study Design Enhanced Surveillance
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives A 10-year Enhanced Surveillance Study (ESS) of the Mobi-C® Cervical Disc Prosthesis to fully characterize adverse events
and complaints when the device is used in the intended patient population under general conditions of use in the United States and in the rest of the world.
The objective is to collect, analyze, and submit all adverse event data.
Study Population All patients who are implanted with the device
The data on AEs will be collected by the company and reported to the FDA:
1. Through literature search (every 6 months for first 2 years and then annually thereafter)
2. AEs reported through company website
3. MDR reports
4. Annual survey of all USA physicians who were trained with the device
Sample Size N/A
Key Study Endpoints All adverse Events will be reported including HO, neurological complications, subsequent surgeries and etc. The data will be
categorized based on severity, and device and MDR relevancy.
Follow-up Visits and Length of Follow-up 10 years
Interim or Final Data Summary
Interim Results A total of 2,666 physicians were identified to survey. Some of these surgeons provided feedback on multiple patients in a single response, and these were treated as separate cases. Of the surgeons surveyed, 200 responded. The overall response rate was 7.1% (200/2,782).
Actual Number of Patients Enrolled N/A
There is no enrollment of patients. All patients who have received this device in the post-market
environment, i.e. all patients who are implanted with the device. The intended patient
population under general conditions of use in the United States and in the rest of the world.
Actual Number of Sites Enrolled N/A
Annual surgeon survey: active collection of surgeon feedback annually to elicit information
related to heterotopic ossification, device malfunction, device removal, or other serious device related
complications.
Patient Follow-up Rate Numbers of sites, IRB approvals and study participants are not available, since this ESS does not
include enrollment of sites/patients. There is no enrollment of patients.
Study Strengths & Weaknesses N/A


Enhanced Surveillance System Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/05/2014 02/04/2014 On Time
one year report 08/07/2014 08/07/2014 On Time
18 month report 02/05/2015 02/09/2015 Overdue/Received
two year report 08/07/2015 08/10/2015 Overdue/Received
three year report 08/06/2016 08/08/2016 Overdue/Received
four year report 10/06/2017 10/06/2017 On Time
five year report 11/06/2018 11/06/2018 On Time
six year report 11/06/2019 11/06/2019 On Time
seven year report 11/06/2020 11/09/2020 Overdue/Received
eight year report 11/06/2021 11/08/2021 Overdue/Received
9 year report 11/06/2022    
ten year/final report 08/07/2023    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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